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Multinational, double-blind, phase III study of prednisone and either satraplatin or placebo in patients with castrate-refractory prostate cancer progressing after prior chemotherapy: The Sparc trial
Journal of Clinical Oncology, 10/08/09

Sternberg CN et al. – Oral satraplatin delayed progression of disease and pain in patients with metastatic CRPC experiencing progression after initial chemotherapy but did not provide a significant OS benefit. Satraplatin was generally well tolerated. These results suggest activity for satraplatin in patients with CRPC who experience progression after initial chemotherapy.

Methods

950 patients
Randomly assigned (2:1) to receive oral satraplatin (n = 635) 80 mg/m2 on days 1 to 5 of 35-day cycle and prednisone 5 mg BID or placebo (n = 315) and prednisone 5 mg BID.
Primary end points were PFS and OS
Secondary end point was time to pain progression (TPP)

Results

33% reduction (hazard ratio [HR] = 0.67; 95% CI, 0.57 to 0.77) observed in risk of progression or death with satraplatin versus placebo
Effect maintained irrespective of prior docetaxel treatment
No difference in OS seen between the satraplatin and placebo arms
Compared with placebo, satraplatin significantly reduced TPP
Satraplatin generally well tolerated, although myelosuppression and GI disorders occurred more frequently with satraplatin

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